Jan 9, 2014
If you access www.ClinicalTrials.gov, a service of the U.S. National Institutes of Health, next week, you will learn of a new clinical study concerning measurement of outcomes in the minimally invasive treatment of knee arthritis. Adult Mesenchymal Stem Cells derived from Bone Marrow that are concentrated and prepared using updated technology is the basis for Regenerative Sciences, LLC Center sponsoring the Trial. The other reason, about six months ago, I changed the discussion concerning outcomes measurements of cellular orthopedics interventions for knee arthritis when I compared my results at one year of stem cell regenerative therapy with my historical results of knee replacement surgery. That paper, delivered at an international stem cell conference, while changing the discourse in the regenerative medicine world, also catalyzed argument among the joint replacement surgeons about the role of stem cells for arthritis of major joints. One valid criticism of my scientific clinical trial was that there had only been a one-year follow-up. The second, a relatively low number of patients in that first of its kind study. The net result is an approval announcement from the Institutional Review Board of the International Cellular Medicine Society: Randomized Controlled Trial of Regenexx SD Versus Exercise Therapy For Treatment of Knee Osteoarthritis with Historical Comparison To Total Knee Arthroplasty.
As in any clinical trial, there are inclusion criteria that must be met before a patient would be considered a candidate for the stem cell intervention. The study itself has IRB restrictions as well. Beside the many benefits of cellular orthopedics for osteoarthritis of the knee, just as anything else in health care, there are Risks and Discomforts. You may become familiar with The Regenexx SD procedure by accessing that web site www.Regenexx.com or when you are seen in my office. There are no experimental tests or procedures in this study. Before a candidate gains entrance to the study, the following procedures are required to evaluate eligibility:
- A knee examination
- Documentation of medical and surgical history and medication usage
- Review of current images (X-rays)
Costs
While there will be no charge for the Pharmacologic portion of the trial (Stem Cell management), study participants or their insurance may be billed for:
- The initial physical evaluation/consultation
- Follow-up office visits after the procedure
- Knee brace if requested
Are you interested and do you meet the inclusion criteria? To learn more call 1-888-525-3005 or contact [email protected]
Tags: arthritis, Clinical Trial. Mitchell B. Sheinkop, Knee, Knee Pain Relief, Orthopedic Surgeon, Osteoarthritis, Regenexx-SD
Apr 9, 2013
Stem Cell intervention is increasingly offered by anyone and everyone with a license to practice. As of this time, there are no certifying bodies or residencies or Board sanctioned fellowships. In my blogs, I have attempted to educate the readers and keep them up to date. Most recently, I posted data pertaining to knee outcomes when compared to a knee replacement. For those of you who might have missed it, I used the standard 100-point Knee Society Assessment Score which all clinical researchers use to compare the results of a cohort of Total Knee Replacement recipients with the outcome of a similar cohort of patients whose arthritis at the knee was treated with Bone Marrow Aspirate Concentrate. Pre-operative, the KSS in the Total Knee Replacement group was 48 points, post-operative at one year, 80 points. You may compare that score with the preliminary sores of BMAC recipients. Pre-intervention, the mean Knee Society Score 68; Post-intervention, 85 and no concern about revision surgery. Only an orthopedic surgeon is trained to properly harvest stem cells from bone marrow and only the orthopedic joint replacement surgeon is experienced and equipped to provide the kind of data I am posting and will continue to publish.
Will the skiers, cyclists, athletes, fitness buffs be able to experience at year four that which they enjoyed at week four following a stem cell intervention at the arthritic hip, knee or ankle? The Outcomes work at Regenexx indicates a positive subjective response from over 70% of patients who underwent a SD Stem Cell procedure 28 months earlier. I am adding to the studies by collecting objective data. How might we improve the success rate and the durability of a BMAC intervention? It would seem the answer to that question is two fold and I have introduced two alternatives in my practice. Only time will tell the better alternative:
1) Should a BMAC recipient experience incomplete relief within four months or the return of symptoms within six months of the procedure, then a Platelet Rich Plasma booster makes sense.
2) Should a BMAC recipient not respond to the PRP booster then a repeat stem cell intervention makes sense.
In the upcoming weeks, I will continue to publish comparisons between the outcomes of BMAC intervention for arthritis and Total Joint Replacement. If you want to “stay active my friend”, give stem cells a chance.
Tags: arthritis, Osteoarthritis, Regenerative Pain Center, Regenexx, Regenexx-SD, stem cells
Feb 3, 2013
I had pain with each step I took. I tried cortisone, Synvisc, Voltarin, with little to no relief. I researched all available surgeries and felt uneasy about their shortcomings and risks. I have been active and healthy all my adult life participating in racquetball, running, cycling, golf, and snowshoeing. To think it came to a point where I found it difficult even to sleep at night – with just the touch of a sheet, my right knee would throb in pain. After receiving my Regennex SD injections on both my “bone on bone” knees, on December 19, 2012 I had “Magical”, immediate, relief.
Three days after my injections I was at the health club doing upper body workouts , swimming, and pool walking. I walked daily increasing from one-half to two miles today. I recently turned 64 yrs. young, and feel it’s “Prime Time” for me. Although I’m still cautious and careful about my knees, I don’t think I will ever play racquetball again. Everything else…………..stay tuned.
I want to thank you, I found the the RIGHT GUY, at the RIGHT TIME, with the RIGHT PROCEDURE….THANKS REGENNEX!!!!
R.R.
Tags: Knee Pain Relief, Regenexx-SD, Synvisc, Voltarin
